Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and treatment with the TomoTherapy Hi
FDA device recall Z-1187-2012 · posted 2012-03-08 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp
- Reason for recall
- Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fields are used. Integra estimates that a target dose decrease of 1.2% would result from a typical 360 degree TomoTherapy arc.
- Action taken
- Integra sent a Product Technical Bulletin dated January 23, 2012, to all affected consignees via FedEx, email or telephone conference calls. The revised Operator Manual was provided with a Technical Bulletin to all consignees that have been shipped this system. Consignees were asked to distribute the information in the bulletin to members of the Radiotherapy Planning Team within their institution. Customers were also asked to sign and return the enclosed Product Technical Bulletin Acknowledgement Form. For questions regarding this recall call 888-772-7378.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 33 units
- Distribution
- Worldwide Distribution - USA including DC, IN, FL, HI, LA, NY, MD, MI, OH,OR, WI, WY, Foreign: Great Britain, Italy, and France
- Date initiated
- 2012-01-23
- Date posted
- 2012-03-08
- Date terminated
- 2012-10-01
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS (K072454) | Integra Radionics, Inc. | 2007-10-16 |